Chengdu Shengnuo Biopharm Co., Ltd.
Form 483 issued September 8, 2023 · Chengdu, China
- Inspection
- Sep 4 – Sep 8, 2023
- Investigator
- Djamila Harouaka
- Observations
- 1
- Pages
- 2
- FEI number
- 3006257504
In short: On September 8, 2023, FDA issued a Form 483 with 1 observation to Chengdu Shengnuo Biopharm Co., Ltd. in Chengdu, China (FEI 3006257504) after an inspection that ran Sep 4 – Sep 8, 2023. The investigator was Djamila Harouaka. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's quality unit does not ensure that manufacturing records are complete, clear…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmChengdu Shengnuo Biopharm Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chengdu Shengnuo Biopharm Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Chengdu Shengnuo Biopharm Co., Ltd.?
Djamila Harouaka is named on this Form 483, for the inspection of Sep 4 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Chengdu Shengnuo Biopharm Co., Ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Chengdu Shengnuo Biopharm Co., Ltd.?
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